CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC

NCT06652412 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FDRT-2024-137-3690
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC. For cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus clinical complete response \[cCR\]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.

Conditions

Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of clinical complete response (cCR) with Watch \& Wait (W\&W) strategy.

  1 month after the surgery or the decision of W&W

Secondary Outcomes (7)

• Grade 3-4 adverse effects rate

  From date of randomization until 3 months after the completion neoadjuvant therapy

• 1 year anal preservation rate

  From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 12 months.

• health-related quality of life (HRQOL)

  baseline, and at 3, 6 and 12 months.

• 1 year disease free survival rate

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• 1 year local recurrence free survival rate

  From date of randomization until the date of first documented pelvic failure, assessed up to 12 months.

Study Arms (2)

CGA cohort

EXPERIMENTAL

in cohort 1, all patients will receive Ultrafractionated RT, PD-1 antibody, and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive single agent chemotherapy and BSC; Fit patients will receive doublet chemotherapy and BSC.

Drug: Ultrafractionated RT and CGA Guided systemic treatment.; Radiation: Ultrafractionated Radiotherapy; Drug: Sintilimab; Drug: Fluorouracil; Drug: Raltitrexed; Drug: Oxaliplatin; Drug: Irinotecan (CPT-11)

external control cohort

OTHER

external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.

Other: data prospectively collected

Interventions

Ultrafractionated RT and CGA Guided systemic treatment. DRUG

in cohort 1, all patients will receive Ultrafractionated RT (1Fx every 3 or 4weeks) and Sintilimab (q3w). Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.

CGA cohort

data prospectively collected OTHER

in cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.

external control cohort

Ultrafractionated Radiotherapy RADIATION

1Fx every 3 or 4weeks

CGA cohort

Sintilimab DRUG

200 mg q3w

CGA cohort

Fluorouracil DRUG

5-Fluorouracil or capecitabine

CGA cohort

Raltitrexed DRUG

Raltitrexed

CGA cohort

Oxaliplatin DRUG

Oxaliplatin

CGA cohort

Irinotecan (CPT-11) DRUG

irinotecan

CGA cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥70y, or, ≥60 and \<70y but ECOG≥2;
• male or female;
• Pathologically confirmed Colorectal adenocarcinoma;
• any distance from anal verge;
• Clinical stage ≥T2 and/or N+, without distance metastases;
• refuse radical operation, physiologically or technically inoperable;
• No previous radiotherapy in the same field；
• No chemotherapy prior to enrollment;
• No immunotherapy prior to enrollment;
• With good compliance during the study
• Signed written informed consent

You may not qualify if:

• Known history of other malignancies within 3 years，except cured skin cancer, cervical cancer in situ or thyroid carcinoma.
• Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
• Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
• Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
• Individuals with autoimmune diseases
• Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases
• Baseline hematology and biochemistry did not meet the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB \<1.5 times the upper limit of normal; Cr \<1 time the upper limit of normal; Alb ≥30g/L
• Individuals allergic to any drug component of the study

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

sintilimab; Fluorouracil; raltitrexed; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Zhen ZHANG Principal Investigator

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen ZHANG Principal Investigator

CONTACT

18801735029; zhen_zhang@fudan.edu.cn

Yan WANG sub-Investigator

CONTACT

18121298388; 11111230025@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 28, 2024

Record last verified: 2024-10